Trauma, Nervous SystemEIMNCT00596609
Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials
An observational study of Trauma, Nervous System, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical correction of the abnormal spinal curvature. The degree of neurologic injury can range from minor sensory deficits to complete paraplegia. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Trauma, Nervous System
- What is being tested?
- Intrathecal Morphine
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children ages 11-18 with idiopathic scoliosis who are scheduled to have a posterior spinal fusion.
Who may be able to join
- Intrathecal Morphine Group:
- All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
- Patients with procedures anticipated to extend to or below the second lumbar vertebral level
- Only patients given intrathecal morphine after curve correction and instrumentation will be studied
- Control Group:
- All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
- Patients with procedures not anticipated to extend to or below the second lumbar vertebral level
- Patients who do not receive IT morphine injection as part of their routine anesthetic care
Who cannot join
- Intrathecal Morphine Group:
- Patients who receive inhaled anesthetic agents before or during the 30 minutes following IT morphine injection
- Patients who receive neuromuscular blocking drugs within an hour before or during the 30 minutes following IT morphine injection.
- Patients who develop significant changes in TceMEPs prior to intrathecal morphine injection
- Patients with intraoperative hemodynamic instability which requires continuous vasoactive drug infusion (e.g., dopamine)
- Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
Show all 14Show fewer
- Pregnant or lactating females
- Control Group:
- Patients who receive inhaled anesthetic agents before or during the 30 minutes following IT morphine injection
- Patients who receive neuromuscular blocking drugs within an hour before or during the 30 minutes following IT morphine injection.
- Patients who develop significant changes in TceMEPs prior to the study interval
- Patients with intraoperative hemodynamic instability which requires continuous vasoactive drug infusion (e.g., dopamine)
- Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadephia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effects of Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials in Patients Undergoing Posterior Spine Fusion
Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical correction of the abnormal spinal curvature. The degree of neurologic injury can range from minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to identify impending neurologic injury. These consultants monitor spinal cord pathways by recording and analyzing evoked potentials during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory neural pathways.
Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most commonly used anesthetic agents have well-characterized effects on evoked potentials, little data exists on the effects of IT morphine on transcranial electric motor-evoked potentials (TceMEPs).
This is a prospective observational study to characterize the effects of IT morphine on TceMEPs.
Read the detailed description
Posterior spinal fusion surgery (PSF) is associated with significant postoperative pain. Numerous postoperative pain management strategies have been employed for patients undergoing these procedures, including continuous narcotic infusions, intravenous patient-controlled opioid analgesia, epidural analgesia, intrathecally administered narcotics, and combinations of these regimens. Most patients at CHOP have their pain managed with intravenous patient-controlled opioid analgesia alone or in combination with a single dose of intra-operatively administered intrathecal (IT) morphine.
Patients undergoing spinal fusion procedures are also at risk for perioperative neurologic injury. Surgeons at CHOP and other institutions routinely utilize neurophysiologists to evaluate at-risk neural pathways to identify impending spinal cord and spinal nerve root injury. These consultants monitor motor and sensory pathways by recording and analyzing evoked potentials and electromyography during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory nerves.
At CHOP, IT morphine is injected by the surgeon after the scoliotic curvature has been corrected and spinal instrumentation is complete. This injection therefore occurs after the critical period for neurophysiologic monitoring and risk of spinal cord injury. It is injected after the neurophysiologist has given a reassuring assessment of neural integrity. This injection is given to patients who have spinal fusions extending below the second lumbar vertebral body. Injections are limited to this group of patients because the appropriate intervertebral spaces for intrathecal injection are not exposed in procedures that do not extend below this level.
Most commonly used anesthetic agents have well-characterized effects on evoked potentials. The effects of IT morphine on sensory-evoked potentials have been studied. However, little data exist on its effects on transcranial electric motor-evoked potentials. This study aims to characterize these effects; we hypothesize that intrathecal morphine has no effect on transcranial electric motor-evoked potentials in the doses used at our institution.
- Conditions
- Trauma, Nervous System
- Being tested
- Intrathecal Morphine
- Keywords
- Injections, intrathecal, Transcranial, Spinal Fusion, Evoked Potentials, Motor
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
- In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled "Baseline." These will serve as controls for subsequent recording comparisons.
- In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group 1 will be subjects who receive Intrathecal Morphine. Receives: Drug: Intrathecal Morphine | |
| 2 | Group 2 will be subjects who do not receive Intrathecal Morphine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation
Measured: 30 minute period - Group 1 - after IT morphine injection or during skin closure for Group 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, Nervous SystemStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Investigators
- Paul Stricker, MD, Principal investigator, Children's Anesthesiology Associates, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596609
- Sponsor's protocol ID
- 2007-4-5176
- Acronym
- EIM
- Status last verified
- Sep 2009
- First submitted
- 9 Jan 2008
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrathecal Morphine on Transcranial Electric Motor-Evoked Potentials in Patients Undergoing Posterior Spine Fusion
- ClinicalTrials.gov ID
- NCT00596609
- Acronym / sponsor ID
- EIM / 2007-4-5176
- Conditions
- Trauma, Nervous System
- Keywords
- Injections, intrathecal, Transcranial, Spinal Fusion, Evoked Potentials, Motor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical correction of the abnormal spinal curvature. The degree of neurologic injury can range from minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to identify impending neurologic injury. These consultants monitor spinal cord pathways by recording and analyzing evoked potentials during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory neural pathways.
Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most commonly used anesthetic agents have well-characterized effects on evoked potentials, little data exists on the effects of IT morphine on transcranial electric motor-evoked potentials (TceMEPs).
This is a prospective observational study to characterize the effects of IT morphine on TceMEPs.
Detailed description
Posterior spinal fusion surgery (PSF) is associated with significant postoperative pain. Numerous postoperative pain management strategies have been employed for patients undergoing these procedures, including continuous narcotic infusions, intravenous patient-controlled opioid analgesia, epidural analgesia, intrathecally administered narcotics, and combinations of these regimens. Most patients at CHOP have their pain managed with intravenous patient-controlled opioid analgesia alone or in combination with a single dose of intra-operatively administered intrathecal (IT) morphine.
Patients undergoing spinal fusion procedures are also at risk for perioperative neurologic injury. Surgeons at CHOP and other institutions routinely utilize neurophysiologists to evaluate at-risk neural pathways to identify impending spinal cord and spinal nerve root injury. These consultants monitor motor and sensory pathways by recording and analyzing evoked potentials and electromyography during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory nerves.
At CHOP, IT morphine is injected by the surgeon after the scoliotic curvature has been corrected and spinal instrumentation is complete. This injection therefore occurs after the critical period for neurophysiologic monitoring and risk of spinal cord injury. It is injected after the neurophysiologist has given a reassuring assessment of neural integrity. This injection is given to patients who have spinal fusions extending below the second lumbar vertebral body. Injections are limited to this group of patients because the appropriate intervertebral spaces for intrathecal injection are not exposed in procedures that do not extend below this level.
Most commonly used anesthetic agents have well-characterized effects on evoked potentials. The effects of IT morphine on sensory-evoked potentials have been studied. However, little data exist on its effects on transcranial electric motor-evoked potentials. This study aims to characterize these effects; we hypothesize that intrathecal morphine has no effect on transcranial electric motor-evoked potentials in the doses used at our institution.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Intrathecal MorphineGroup 1 will be subjects who receive Intrathecal Morphine. |
| 2 | – | –Group 2 will be subjects who do not receive Intrathecal Morphine. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children ages 11-18 with idiopathic scoliosis who are scheduled to have a posterior spinal fusion.
Key inclusion criteria (8 listed)
- All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
- Patients with procedures anticipated to extend to or below the second lumbar vertebral level
- Only patients given intrathecal morphine after curve correction and instrumentation will be studied
- All patients with idiopathic scoliosis aged 11 through and including 18 who present to CHOP for posterior spinal fusion will be eligible
- Patients with procedures not anticipated to extend to or below the second lumbar vertebral level
Key exclusion criteria (14 listed)
- Patients who receive inhaled anesthetic agents before or during the 30 minutes following IT morphine injection
- Patients who receive neuromuscular blocking drugs within an hour before or during the 30 minutes following IT morphine injection.
- Patients who develop significant changes in TceMEPs prior to intrathecal morphine injection
- Patients with intraoperative hemodynamic instability which requires continuous vasoactive drug infusion (e.g., dopamine)
- Patients with neuromuscular, congenital, or other non-idiopathic scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal Morphine* In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled "Baseline." These will serve as controls for subsequent recording comparisons. * In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection. | Drug | 1 |
Primary outcome
To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation
Time frame: 30 minute period - Group 1 - after IT morphine injection or during skin closure for Group 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Stricker, MD principal investigator
Children's Anesthesiology Associates, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Nervous System, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantitatively evaluate the effects of IT morphine on TceMEP amplitude and latency in patients undergoing PSF who have IT morphine injected after instrumentation (time frame: 30 minute period - Group 1 - after IT morphine injection or during skin closure for Group 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2009.